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Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy

NCT04571216 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2025-06-19

No results posted yet for this study

Summary

CESTO 2 is a 318 participants, 3-arm, multicentric, randomized, double-blind, placebo-controlled Phase II clinical trial.

The main objectives are to select the most efficient dose and to assess long-term efficacy of NFL-101 compared to placebo, for abrupt cessation and for reduction before cessation.

Conditions

  • Smoking Cessation
  • Nicotine Dependence

Interventions

DRUG

NFL-101 dose 1

Subcutaneous injections

DRUG

NFL-101 dose 2

Subcutaneous injections

DRUG

Placebo

Subcutaneous injections

Sponsors & Collaborators

  • NFL Biosciences SAS

    lead INDUSTRY

Principal Investigators

  • Yves Donazzolo, MD · Optimed Eurofins

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2024-04-12
Completion
2024-04-12

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04571216 on ClinicalTrials.gov